Multicenter Human Trial For NOTES® Enrolling Patients

The Natural Orifice Surgery Consortium for Assessment and Research® (NOSCAR®), a joint effort of the American Society for Gastrointestinal Endoscopy (ASGE) and the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES), announces that institutions selected to participate in a multicenter human trial on transoral and transvaginal cholecystectomies (gallbladder removal) using Natural Orifice Translumenal Endoscopic Surgery® (NOTES®) are enrolling patients to take part in the study.

Cholecystectomy, or gallbladder removal, is one of the most common surgeries in the U.S.; approximately 750,000 are performed annually. The NOSCAR study uses the mouth or vagina as routes to the gallbladder. Rather than making up to five incisions in the abdominal wall, tools are passed down the mouth and through a hole created in the stomach (transoral/transgastric) or through the vagina (transvaginal).

The prospective multicenter trial compares NOTES cholecystectomy versus conventional laparoscopic cholecystectomy. NOSCAR has granted funds to selected institutions to conduct these trials. Institutions participating in the trial have demonstrated a strong commitment to developing the basic science that forms the foundation of NOTES and have already performed human NOTES cases under an Institutional Review

Board protocol; approximately two hundred patients will be enrolled in the clinical trial. If a patient is interested in participating or referring someone into this study, please contact one of the following sites: